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Posted 04 May 2018 | By Ana Mulero
Major changes are afoot at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and a number of voluntary pilot programs for industry will be key in determining the direction they are heading, officials said at the 2018 FDA/Xavier MedCon conference on Thursday.
The Medical Device Single Audit Program (MDSAP) is among the voluntary programs that will help shape regulatory harmonization. Interest in the program, a pillar of the International Medical Device Regulators Forum (IMDRF), could benefit from more harmonization and has continued to gain momentum.
As illustrated in the graphic below, the auditing program has recently seen major spikes in the total number of participating manufacturer sites, totaling 1,749 in Q1 2018—up from just 788 in 2017.